Meropenem I — Class II drug recall D-0303-2015
Terminated recall by Hospira Inc., reported 2014-12-24, distributed nationwide. Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which ma
| Recall number | D-0303-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-10-24 |
| Classified | 2014-12-18 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2016-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, IT |
| Quantity | 261,706 vials |
| Reason classes | foreign material, sterility, specification failure, packaging |
| NDC | 00409-3506-01 |
| Lot numbers | 1J/2016, 601E025, 601E027, 601E028A, 601E028B, 601E028C, 609E014, 609E015, 609E016, 609E017, 609E018, 609E019 |
| Expiration dates | 2016-01 |
Product
Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01
Reason for recall
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0303-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.